Ms Tammy Thomas FD, MPH (ongoing)

Trial Manager

Ms Tammy Thomas is a Trial Manager within Medicine at the University of Southampton.

As a research manager my primary role is to make sure the projects are delivered on time and to target, resulting in effective evidence to shape future practice.

Tammy joined the University of Southampton in 2002, starting as a clerical assistant in the School of Ocean and Earth Sciences at the then Southampton Oceanography Centre, providing support to the post and under graduate secretaries and an emeritus professor. In 2004 Tammy joined the team at PMC in trial administration and also worked for the WREN Research, Management and Governance Unit until 2008 when she began managing primary care studies.

Tammy graduated in Health and Social Care, University of Southampton in 2011 and is currently working towards an MPH at the University of Manchester.

Tammy is currently managing an NIHR School of Primary Care Research funded feasibility pilot study, Fatigue: acute fatigue Assessment and Management in Everyday practice (FAME) and is a regional coordinator for an open, adaptive, randomised trial, running in 20 EU countries during periods of increased influenza incidence, being led by Oxford; Antivirals for influenza-like illness? An rCt of Clinical and Cost effectiveness in primary CarE (ALIC4E). – The ALIC4E trial will be delivered as work package (WP) 4 of the (PREPARE) consortium grant. In addition to these two Tammy is a regional coordinator for an individually randomised placebo controlled three-arm superiority trial with cost effective analysis, qualitative evaluation and a parallel observational cohort; The CEDAR (Children’s Ear Pain) Study, being led by Bristol.

FAME - Fatigue is the listed incident complaint in relatively few consultations - 5-10 per 10,000. However, fatigue is usually ‘hidden’ and not documented as the main complaint: 5-10% of attenders in primary care rate it as a major problem, tired all or most of the time for at least a month. An example is sore throat, where 50% will present with glands and fever (from the DESCARTE study n=14,000): significant fatigue is likely to be present in 47% of this phenotype, and 9-22% of these will go on to develop chronic fatigue and yet fatigue is almost never initially coded. Because fatigue is not recognized, there is little help provided to manage what can be one of the most dominant, distressing and disabling of symptoms. The feasibility study (Stage 1) will provide information about recruitment and attrition rates, logistic issues relating to the feasibility and acceptability of all the cohort procedures (different methods of recruitment, questionnaire length, timing and content; method of contact (text or email), taking of blood and urine samples etc.); and attributes of the cohort (e.g. preliminary estimates of the likely difference in characteristics between the different clinical presentations).

ARCHIE - This is a double-blind randomised placebo-controlled trial whose primary objective is to determine whether treatment with a 5-day course of co-amoxiclav early during an influenza/ILI episode in at risk children reduces the likelihood of re-consultation due to clinical deterioration. ‘At risk’ children aged 6 months to 12 years inclusive who present in primary care or other equivalent ambulatory care settings with influenza/ILI and meet our trial eligibility criteria will be invited to join the trial. For each child entering the trial a healthcare professional will complete a baseline assessment and obtain two swabs: a nasal swab for detection of influenza by Polymerase Chain Reaction (PCR) and a throat swab for bacterial culture and sensitivity. Participants will be randomised to receive either co-amoxiclav 400/57 or placebo, which will be taken orally twice daily for 5 days. Parents/guardians of trial participants will be given a study diary in which to record doses of study medication given to the child, temperature, symptoms and adverse events. Parents/guardians will also be asked to record in their study diaries items relating to healthcare resource utilisation, parent or child burden. Children will be given a diary where they will have the opportunity to record medication taken and document how they are feeling each day.

CEDAR - Acute Otitis Media (AOM) is a common, painful condition of childhood. Children with AOM require adequate symptom control, including analgesia. Antibiotics are not analgesics, but are commonly used and lead to increased antimicrobial resistance and side effects. Evidence of effectiveness for alternatives to antibiotics is urgently needed to reduce reliance on antibiotics and to relieve the most common and distressing symptoms of AOM. The CEDAR trial supports the overarching goal of the UK’s Five Year Antimicrobial Resistance Strategy and Action Plan (2013 to 2018), and specifically its second strategic aim, to conserve and steward the effects of existing antibiotics by investigating if an antibiotic alternative (an anaesthetic ear drop) is effective in reducing reliance on, and consumption of, antibiotics.

ALIC4E The ALIC4E Trial, Work Package 4 within PREPARE - Platform for European Preparedness Against (Re-) emerging Epidemics, is a large multicentre study in primary care with patients presenting with influenza-like-illness (ILI). This trial will combine three aims, first, to investigate the (cost) effectiveness of antiviral treatments for ILI in primary care; second, to establish a European primary care network for clinical research during epidemics or pandemics; third, to define recommendation for effective research in European primary care during an epidemic or pandemic.

Treatment of patients with ILI largely varies in the primary care setting around the globe. In Japan, ILI patients are treated with antivirals, in the USA, high-risk patients (defined by age and comorbidity) receive antiviral treatment, whereas in Europe, where antivirals are used in the hospital setting, routine use in primary care is very rare.

Antiviral treatment with oseltamivir has been shown to decrease duration of illness, prevent virus spread, and possibly reduce the risk of complications. In this respect, two important aspects have not been investigated before. First, whether antiviral treatment is more effective for specific subgroups of patients (high-risk patients) and second, whether antiviral treatment is a cost-effective approach. Due to the adaptive trial design of ALIC4E it is possible to include new promising antiviral agents during the course of the trial.

Research

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Research interests

2016 – CEDAR (Children’s Ear Pain) Study, University of Bristol, a paediatric individually randomised placebo controlled three-arm superiority trial with cost effective analysis, qualitative evaluation and a parallel observational cohort. The CEDAR trial supports the overarching goal of the UK’s Five Year Antimicrobial Resistance Strategy and Action Plan (2013 to 2018), and specifically its second strategic aim, to conserve and steward the effects of existing antibiotics by investigating if an antibiotic alternative (an anaesthetic ear drop) is effective in reducing reliance on, and consumption of, antibiotics.

2015 – ARCHIE Study, University of Oxford, a paediatric double-blind randomised placebo-controlled trial to determine whether treatment with a 5-day course of co-amoxiclav early during an influenza/ILI episode in at risk children reduces the likelihood of re-consultation due to clinical deterioration.

2014 – FAME Study, University of Southampton, A pilot study to inform a future study in the management of short-term (acute) fatigue.

2008 – SNIFS Study, University of Southampton, A primary care randomised controlled trial of nasal irrigation, steam inhalation and a combination of the treatments to ascertain effectiveness in the prevention of sinusitis symptoms.

Affiliate research group

Research project(s)

Infectious diseases are a major threat to human wellbeing and economic and social development. Influenza, a highly contagious virus, causes a common respiratory infection with local and systemic symptoms.